Myelodysplastic Syndrome Clinical Trial

ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Summary

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.

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Full Description

The study consisted of a 4-week Screening Period and a 26-week Randomized Treatment Period (Primary Evaluation Period). After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive ravulizumab for up to 3 years.

The data presented is up to the Primary Completion date of the study and is for the Primary Evaluation Period. The results for the Extension Period will be reported after study completion.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female ≥18 years of age.
Treated with eculizumab for PNH for at least 6 months prior to Day 1.
Lactate dehydrogenase level ≤1.5 times the upper limit of normal (ULN) at screening.
PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
Willing and able to give written informed consent and comply with study visit schedule.

Exclusion Criteria:

History of bone marrow transplantation.
Body weight <40 kilograms at screening.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleeding, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, or coexisting chronic anemia unrelated to PNH).
Female participants who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or Day 1.
Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study treatment on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

195

Study ID:

NCT03056040

Recruitment Status:

Completed

Sponsor:

Alexion Pharmaceuticals

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There are 49 Locations for this study

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Clinical Trial Site
Duarte California, 91010, United States
Clinical Trial Site
Los Angeles California, 90033, United States
Clinical Trial Site
Baltimore Maryland, 21205, United States
Clinical Trial Site
Detroit Michigan, 48202, United States
Clinical Trial Site
Bronx New York, 10467, United States
Clinical Trial Site
Canberra Australian Capital Territory, 2605, Australia
Clinical Trial Site
Kogarah New South Wales, 2217, Australia
Clinical Trial Site
Liverpool New South Wales, 2170, Australia
Clinical Trial Site
Woolloongabba Queensland, 4102, Australia
Clinical Trial Site
Parkville Victoria, 3050, Australia
Clinical Trial Site
Toronto Ontario, M4N 3, Canada
Clinical Trial Site
Toronto Ontario, M5G 2, Canada
Clinical Trial Site
Montréal Quebec, H1T 2, Canada
Clinical Trial Site
Amiens , 80054, France
Clinical Trial Site
Marseille , 13273, France
Clinical Trial Site
Paris , 75475, France
Clinical Trial Site
Pierre-Bénite , 69495, France
Clinical Trial Site
Saint-Priest-en-Jarez , 42271, France
Clinical Trial Site
Strasbourg , 67091, France
Clinical Trial Site
Ulm Baden Wuerttemberg, 89081, Germany
Clinical Trial Site
Aachen Nordrhein Westfalen, 52074, Germany
Clinical Trial Site
Essen Nordrhein Westfalen, 45147, Germany
Clinical Trial Site
Firenze , 50134, Italy
Clinical Trial Site
Milano , 20122, Italy
Clinical Trial Site
Napoli , 80131, Italy
Clinical Trial Site
Torino , 10126, Italy
Clinical Trial Site
Vicenza , 36100, Italy
Clinical Trial Site
Kanazawa-shi Ishikawa, 920-8, Japan
Clinical Trial Site
Suwa Nagano, 392-8, Japan
Clinical Trial Site
Suita-shi Osaka, 565-0, Japan
Clinical Trial Site
Shinagawa-Ku Tokyo, 141-8, Japan
Clinical Trial Site
Fukushima , 960-1, Japan
Clinical Trial Site
Daegu , 42415, Korea, Republic of
Clinical Trial Site
Daejeon , 35015, Korea, Republic of
Clinical Trial Site
Gyeonggi-do , 14584, Korea, Republic of
Clinical Trial Site
Gyeonggi-do , 16247, Korea, Republic of
Clinical Trial Site
Incheon , 21565, Korea, Republic of
Clinical Trial Site
Seoul , 03080, Korea, Republic of
Clinical Trial Site
Seoul , 03722, Korea, Republic of
Clinical Trial Site
Seoul , 06351, Korea, Republic of
Clinical Trial Site
Seoul , 06591, Korea, Republic of
Clinical Trial Site
Maastricht , 6229, Netherlands
Clinical Trial Site
Nijmegen , 6525, Netherlands
Clinical Trial Site
Barcelona , 08036, Spain
Clinical Trial Site
Madrid , 28040, Spain
Clinical Trial Site
Majadahonda , 28222, Spain
Clinical Trial Site
Airdrie , ML6 9, United Kingdom
Clinical Trial Site
Leeds , LS9 7, United Kingdom
Clinical Trial Site
London , SE5 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

195

Study ID:

NCT03056040

Recruitment Status:

Completed

Sponsor:


Alexion Pharmaceuticals

How clear is this clinincal trial information?

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